Verbatim report of proceedings

Tuesday, 11 April 2000 - Strasbourg

10. Deliberate release into the environment of GMOs

  President. – The next item is the recommendation for second reading (A5-0083/2000) by Mr Bowe, on behalf of the Committee on the Environment, Public Health and Consumer Policy, on the common position adopted by the Council with a view to adopting a European Parliament and Council directive amending Directive 90/220/EEC on the deliberate release into the environment of genetically modified organisms (11216/1/1999 – C5-0012/2000 – 1998/0072(COD)).

  Bowe (PSE), rapporteur. – Mr President, I think that today the European Parliament is faced with one of its more important debates in the last few years, given that it is dealing with the dangers of the release of genetically modified organisms into our environment. It seems to me that this vote could be a watershed. It would, we hope, give us a new tough set of rules that would ensure that genetically modified crops and other GMO products are used throughout Europe in a safe and sensible way that ensures protection of the environment and guarantees the safety of public health.

There are a number of critical issues which need to be addressed. The first and the most important is the issue of producer liability. The European Parliament has long called for legislation which would ensure that companies that want to produce genetically modified organisms would be totally responsible for the products they produce. In other words, under the terms of the amendments, companies would be required to take out insurance to cover any possible damage to human health or the environment caused by GMOs and could be sued if their crops escaped and created super-wheats or contaminated organic crops or if GM crops were found to damage human health.

Regrettably, instead of accepting their full responsibilities, a number of companies have been launching massive campaigns behind the scenes to try and stop this proposal from advancing.

I am in no doubt that when we have the discussion tomorrow many MEPs will be confused and perhaps split in their vote on this issue. I feel that the compromise we have found with the Christian Democrats is one that is viable and workable and I hope it will find support here. At the same time the European Commission can endorse it by giving further reassurances about their own proposals for such a liability measure.

I want to see that European Commission proposals have real teeth when it comes to this Parliament in the not too distant future. In addition to that critical issue there are also a number of other important questions. I hope that tomorrow my colleagues will renew their support, as they did at first reading, for the demands for strong new limits on the use of GMOs containing genes with resistance to antibiotics. Parliament has in the past called for a ban on all GM crops and foods containing such antibiotic-resistant genes, even those used for research.

Tomorrow we may take a softer line, but nevertheless we want to see action in this area. We want to ensure that serious consideration is given to the dangers of using these crops.

Other measures that I think we need – and on which I would seek the support of the Parliament tomorrow – include new measures to restrict the dangers of the cross-breeding of GMO plants with naturally occurring wild relatives. We need to ensure that when products are placed in the field, whether they are plants or whether they are animals, they do not cross-breed and irreparably damage the balance that exists in the natural environment around them.

We must also address an issue which was avoided at first reading, and that is the question of the control of the import and export of GMO crops and other GMO products. Here we need to go to at least as far and perhaps beyond the measures agreed in the Bio-Safety Protocol in Montreal in January. Many people fear the possible consequences of genetic pollution and it is our job to respond to those fears. Those fears have recently been heightened by the discovery of GMO-contaminated cotton-seed imported from the USA into Greece for cotton production, which for the moment at least has no approval at all for commercial planting within the EU but nevertheless has found its way across our borders and into use in at least one Member State.

We have been lobbied by very many groups during the process of developing this legislation. Not just the industry but also Friends of the Earth and Greenpeace have given their backing to various aspects of Parliament's report. They have supported us in continuing to press the Council of Ministers to agree on new GMO rules on licensing as quickly as possible, to bring to an end the de facto moratorium on new GMO commercial approvals, which has been in operation since the Commission published its proposal almost two years ago.

The lobbying has become quite intense in the last few weeks. The outcome of the vote in Parliament tomorrow is likely to bring a few shocks and surprises. But it should mean that in six months' time the European Parliament, the Council of Ministers and the Commission will have arrived at an agreed proposal, at a revised directive for the commercialisation of biotechnological inventions and biotechnological products. That should give biotechnology companies and others involved in the industry a clear idea of the rules that they have adhere to and consequently a more transparent and predictable regime. That can be only good for the future development of this new technology within the European Union.

At the same time, I would hope that our governments will be able to assure their consumers and their people that GMOs released into the environment anywhere in Europe will meet the much more stringent standards that we are fixing here in Parliament tomorrow and that the public concerns regarding the protection of human health and the environment from the dangers of GMO inventions have been properly addressed. And I hope one of the significant non-legislative outcomes of this process will be a shift in the balance of power in the approval and control of GMO crops and food in favour of the public. For the biotechnology industry that can only be to the good. It will create an atmosphere, a situation in which it can work carefully, thoroughly and I hope successfully to make positive use of this very brave new technology that we should all welcome, with the appropriate safeguards.

  Liese (PPE-DE). – (DE) Mr President, Commissioner, ladies and gentlemen, I should like to start by thanking the rapporteur, David Bowe, for his hard work. He really has tried to find compromises on this complicated issue but has not succeeded in finding compromises in all areas which all the Groups here in the House are able to support, which is why we shall be voting on one or two points tomorrow.

Those who know me know that I am not a blind advocate of genetic engineering. Many aspects worry me. I even have mixed feelings about the announcements which we heard last week on the almost complete decoding of the human genome because I think that we do not yet have enough strict rules in the European Union on the application of biotechnology to human beings in this way.

However, today we are debating the release of genetically modified organisms, especially plants. And in my view, and in the view of the PPE, this is a different kettle of fish. The common position is not too weak to guarantee public safety, as some would have us believe; on the contrary, it is very, very strong. It makes provision for a great many rules to govern monitoring, labelling and informing the public. The common position offers an adequate level of safety for both man and the environment, which is why the PPE is against tightening up the common position, especially in certain critical areas.

If certain amendments calling for stricter provisions are accepted, then we can kiss biotechnology in the area of plants goodbye and we can totally ban it right away, but that is not what we want to do.

Take the example of genetic transfer. All we hear about are Frankenstein plants and superweeds. However, if you study the subject in detail, you will see that it is not a fact that cross-pollination from genetically modified plants is always an environmental disaster. I have a key witness here. The former research policy spokesperson for the Greens in the Bundestag once said that no Frankenstein plants were growing in the fields. Unfortunately, the Greens did not nominate him again for the Bundestag, but he is right nonetheless, which is why we have tabled a motion stating that we should keep an eye on these risks but not totally ban genetic transfer.

We are also opposed to discrimination against biotechnology when it comes to liability. We do not want specific genetic engineering liability, we want general environmental liability. It has frequently been said that the Commission must be forced to do something at long last. I share that view but we must first praise Mrs Wallström here: she promised during the hearing in the European Parliament that she would present a White Paper on environmental liability and she has done so. Her predecessor failed to do so for several years and we should now move forward on the basis of this White Paper and decide on specific liability rules to be incorporated in the directive.

The common position is not too weak; in our view it is too strong on certain points. The general 10-year limitation on release consent is impracticable for plant cultivation, which is why we support the motion tabled here by David Bowe that the 10-year period should only apply from the first registration of the plants.

I think that the common position gives us good control of the risks. We should not make the mistake of gambling away biotechnology’s chances, which is why we shall not be voting in favour of all the tabled amendments.

  Lund (PSE). – (DA) I should like first of all to thank Mr Bowe for the work that has been done on the recommendation for second reading on amendment of the directive on the deliberate release into the environment of genetically modified organisms. I think it is a very competent piece of work, and I think some important improvements have been made to the common position. I shall single out the points I think are most important. First and foremost, I think it is right that we should now have an actual ban proposed on the use of substances which can produce resistance to antibiotics. I think it is important for health reasons. The second point I would make is that, unlike Mr Liese, I am in favour of including proposals to the effect that measures should, if possible, be taken to prevent gene-transfer from GMOs to other organisms, otherwise known as GMO contamination. I also think it is important that risks should not be assessed on a case-by-case basis when applications and requests concerning consents are examined. Instead, an attempt should be made to carry out an overall assessment of the accumulated effects of the many consents which are issued upon the fertility of the soil, the food chain, biological diversity and the health issues which are of importance to us as human beings. I think that is a major flaw in current practice in this area. In this connection, I also think that consents ought to be reviewed every ten years, so that they can only be issued for up to ten years at a time. In that way, we can be properly sure that the necessary monitoring is carried out.

I also think it is right that this proposal should provide us with legislation ensuring that, whenever vertical legislation is enacted in specific areas, the same conditions regarding risk assessment and monitoring should be complied with as also apply in the case of the general directive. Finally, I would call attention to the question of objective liability. I agree with the original proposal in Mr Bowe’s report to the effect that businesses seeking consents should be made objectively liable and that liability insurance must also be taken out in connection with an application for consent. If insurance cannot be taken out to cover such circumstances, then the risk in granting a licence is too great. I hope we shall see the adoption of these amendments designed to tighten up on the common position. If they are adopted, I also believe we shall obtain a legal basis for granting future consents for GMOs which serves our interests and which will provide the necessary security. In that way, we shall, in actual fact, obtain the legal basis that should have been in place before the first consent for new GMO crops was issued. In my opinion, the present legal basis is far too weak.

  Maaten (ELDR). – (NL) Mr President, I would like to stress that this is a debate on procedural questions regarding the deliberate release into the environment of genetically modified organisms, or GMOs. Contrary to what one might think, this is not a fundamental debate on the pros and cons of GMOs or its principles, for that matter. Needless to say, how we perceive GMOs will be reflected in the positions we adopt during the discussion about these procedures and the framework around them. In simple terms: in the extensive amendments to this report, which is excellent by the way, the most important aspect seems to be that either we decide to make life easier for the GMO industry or we decide to give it sleepless nights.

But the discussion also reveals that the production of genetically modified food has prompted quite a few questions: ethical and moral questions, questions related to public health and the environment, questions as to what opportunities industry and research are given and questions regarding the freedom of choice for consumers.

The following points are key issues for the Liberal group and these will also influence our voting behaviour.

First and foremost, there is the issue of the freedom of choice for consumers. It is, of course, too crazy for words, really, that if you want GM-free food, you will need to settle for food with a guaranteed maximum GMO content of 1%. This is not dealt with as such in the draft directive but public information, labelling and transparency which crop up in this context are very much part and parcel of this issue.

Secondly, we would like to see the public have plenty of opportunity to have its say during the approval procedure of GMOs.

Thirdly, we would welcome a streamlined procedure that offers security to both consumers and producers and, as far as we are concerned, better harmonisation throughout the European Union.

Fourthly, we would like to see research promoted in Europe in the field of biotechnology so as to offer more clarity regarding what is and is not feasible.

One controversial issue is producer liability. We are in favour of the self-regulating effect this has. Ideally, we would like to see this liability included in the long-awaited horizontal regulation of environmental liability. However, some of us are tired of waiting for this horizontal regulation in which the Commission has been engrossed for some 10 years now, and we want to move forward. The present proposal is important to both producers and consumers and is welcomed by the liberal group. We, too, would like to congratulate the diligent rapporteur on this report.

  Breyer (Verts/ALE). – (DE) Mr President, tomorrow’s vote will be a litmus test of Parliament’s responsibility and credibility. The main point, for us, is liability and compulsory insurance. If genetic engineering is as risk-free as the industry and Mr Liese insist, then why is there such huge resistance to strict liability? We too want general environmental liability, but we know that no provision is made for the corresponding liability for genetic technology or for general liability in the Commission proposal, which is why we have proposed compromise Amendment No 45, containing just that. Anything else would amount to

hiding behind a long-term policy of wait-and-see and endless prevarication.

It is ridiculous to say that all we are asking is that the Commission should do this by the year 2001. What will happen if it does not do so? What will happen if horizontal environmental liability does not properly cover the area of genetic technology or, Mrs Wallström, as you suggest, only covers the Natura 2000 areas?

The second main point for us is the ban on antibiotic-resistant genes. We need a clear ban here. I cannot understand, Mr Bowe, why you said that we will take a softer line tomorrow. Is that your sop to the genetic engineering industry? I think that it is quite clear – as scientific studies have proven – that more and more human pathogens are becoming resistant and it would be a disaster if antibiotics were to be permanently lost as a form of treatment.

My last point concerns genetic contamination. I think that we need a clear commitment here on the part of the Member States and I hope that tomorrow’s vote will send out a clear signal on environmental and consumer protection and that tomorrow will not be a black day in the history of environmental and consumer protection.

  Sjöstedt (GUE/NGL). – (SV) Mr President, where the release of genetically modified crops into the environment is concerned, the precautionary principle must be the decisive factor. At present, it ought to entail a moratorium on the release of new genetically modified crops into the environment. Scientific ambiguities, especially where the risk of dissemination is concerned, and deficiencies in legislation and in the application of international agreements are both factors which justify a moratorium.

We also consider that each EU country should be entitled to have a tougher policy than the EU in this area, and we shall therefore vote against Amendment No 6 concerning a common EU procedure governing the release of genetically modified organisms into the environment.

The proposals to be adopted tomorrow will not go anything like so far as we would have wished. We shall therefore vote in favour of as satisfactory a solution as possible to the issue as a whole. This means that we shall be voting in favour of most, but not all, of the proposals in the Bowe report. We shall be voting in favour of a situation in which those who release genetically modified crops into the environment are held fully liable under civil law. We want to see an end to the use of antibiotic resistance markers We want to see clear, compulsory labelling, and we demand that each application should be dealt with separately, and with no use of simplified application procedures. We are also in favour of having a clear obligation for the provision of information and in favour of recipient countries’ being approved in the case of exports to third countries.

  Berthu (UEN). – (FR) Mr President, the proposal for a directive on procedures for the authorisation of genetically modified organisms has been returned to this House for second reading, even though events since the first reading have done nothing but heighten the fears that we originally expressed.

On 11 February 1999, at first reading, we opposed this proposal since we considered that it in no way controlled the risks that GMOs pose to the environment and to animal and human health and that a straightforward application of the precautionary principle should have resulted if not in the definitive prohibition of the release of these organisms, at least in a moratorium lasting several years. Furthermore, we were critical of the authorisation procedures stipulated in the proposal, which seemed to us too lenient and inordinately centralised.

A year on, studies have been conducted that even more clearly highlight the dangers of releasing GMOs. As recently as last week, a committee of inquiry from the French National Assembly concluded, and I quote, that it ‘considered the placing on the market of new products deriving from genetically modified organisms to be premature’.

In these circumstances, we find the text which has been presented to the House for second reading increasingly outmoded. All our principled objections, including the request for an official moratorium, are all the more relevant today and, as was the case with BSE, we would like to see any country which is convinced that it is running a serious risk being entitled to take national prohibition and safeguard measures.

How is it possible, in this day and age, that we have to demand a right as self-evident as this?

  Van Dam (EDD). – (NL) Mr President, in February 1999, we discussed the revision of Directive 90/220 at first reading. I would remind you that in his contribution, Mr Blokland talked about the importance of the precautionary principle. We are thus delighted that the Council has underlined this principle in the common position. Both in the main body of the Directive itself, notably in Article 1, and in its application, the precautionary principle has been accorded an important role when it comes to weighing it up against economic interests. I mainly have the restriction of the simplified procedure and the attention to GMO traceability in mind. On the whole, we should therefore be satisfied with the present proposals.

We are thankful to Mr Bowe for his report, which once again contains proposals which we are totally behind. We are particularly delighted with the stricter wording related to reducing the risks for consumers.

Compared to Amendment No 32, the original Amendment to Article 28 (1) was more forceful, in our opinion. It very explicitly spelled out the possibility of consulting ethical committees in the case of ethical issues. The present Amendment No 32, on the other hand, only underlines the importance of being open with the public. We regret this toning down.

Finally, I would like to point out that it is not sufficient to map out and restrict the risks pertaining to these new production methods. Plants and animals are not production factors which can simply be manipulated. The biotechnology debate requires an integral ethical approach. We believe that God created the world. Based on this awareness, we need to treat the natural world around us responsibly.

  Bowis (PPE-DE). – Mr President, this is a debate about plant research and plant protection from research. It is a debate about the potential of GMOs for good and their potential for risk, and how you manage that risk. You cannot abolish risk because it is part of our natural environment. We cannot prevent all man-made risk because that would end scientific progress. But we must respond to public concern about the potential and unknown dangers to our environment, to our food chain and to our health.

I believe there are four areas where we must act to reassure the public. I believe we can do so without destroying biotechnology. Firstly, antibiotic-resistant genes must be phased out. The amendment sets a realistic, but urgent date of 2005 for that. Secondly, we must be open with the public about where experimental crops are being grown. That is only right. It is fair. In return we must ask environmental action groups to show restraint and responsibility with regard to that knowledge. Thirdly, we must build on the Montreal Protocol as far as the export of GMOs is concerned, and this should be done on the basis of mutual agreement and transparency. Fourthly, as many Members have said, we must ensure liability; but it is a question of whether we need any greater liability than applies to other environmental risks. I suspect we do not, so long as we already have criminal, civil, product and environmental liability in law. That should suffice, but it is wise to add the provision on negligence as something which can be brought into play within the courts.

We can gain real benefits from GMOs if we get it right. Fewer crop sprays, for example, would benefit the environment if we grew GMO crops that did not need so many crop sprays. But we have to take the public with us, with the science. I believe these measures will help to do just that.

  McKenna (Verts/ALE). – Mr President, ideally GMOs should not be released into the environment. But if it is going to happen there have to be a number of measures taken to ensure that the industries that say this technology is safe take responsibility. That is why I cannot understand why the industry and the lobbyists are so concerned about the issue of liability. If they are so sure that their products are safe then why are they afraid to take responsibility, both as regards liability and compensation?

The other issue I should like to address is the contamination of gene transfer. We have a situation where, for example, conventional farms can be contaminated with GMOs. That means there is no free choice, either for the farmers themselves – and that goes for organic farmers too – or for the consumers, in the long run. If you have contamination of conventional farms or organic farms, there is basically no free option for the consumer. This is not acceptable. At the end of the day, the GMO industry does not have anything to offer the consumer or the environment, even as regards the use of chemicals. It is ironic to think that the same industries that are promoting this so-called chemical-free agriculture are the very same ones that have bombarded us with chemicals over the years and are making those crops reliant on chemicals in the future as well.

  González Álvarez (GUE/NGL). – (ES) Mr President, I would like to thank Mr Bowe for his report and, in one minute, mention four fundamental questions which have already been discussed.

Firstly, the protection of public health. It seems to us that we should strictly forbid the use of antibiotic-resistant genes. Germany, Luxembourg and Austria have shown the way by banning Novartis maize, which has a gene which is resistant to ampicillin, a wide spectrum antibiotic.

Secondly, the commitment to international agreements. Amendment No 1 refers to the Montreal Protocol and the need to defend biosafety and the consultation of and request for authorisation from non-EU countries for exports.

Thirdly, the civil liability clause, which is clearly necessary for those who are responsible for the release of these genetically modified organisms which may have effects on health or the environment.

Finally, Mr President, the prevention of genetic contamination. This means preventing the spreading of transgenic pollen which may travel and contaminate other plants and, therefore, seriously affect the environment.

  Hyland (UEN). – Mr President, I should like to start by complimenting Mr Bowe on his objective and balanced presentation. In previous debates in Parliament I have put on record my own views in relation to biotechnology. In the short time available, I appeal to the Commission and, indeed, Parliament to urgently expedite the conclusions necessary to allay consumer fears concerning the public health, environmental and ethical aspects of a technology which has the potential to make a significant contribution to food production and public health.

Of course there are concerns on the part of consumers. They are entitled to an in-depth and independent evaluation of what is a rapidly changing technology. The longer we allow the confusion to exist, the greater the delay in enabling society to benefit from its full potential. In this regard the bio-industry has itself contributed in no small way to public unease by the planned introduction of unacceptable practices such as seed-terminator technology and other ethical issues such as experimentation with human embryos. It was the vigilance of this Parliament in particular that raised a warning flag in relation to many aspects of the application of this research.

But there are now welcome indications that the industry has taken on board Parliament's concern in this regard. An indication of the potential of genetic research to make a positive contribution to food production is demonstrated by the very recent announcement by Monsanto of a significant breakthrough on the genetic structure of rice, which is the staple food on which millions in the developing world depend and about which there is considerable concern with regard to the continuity of supply.

The bottom line in relation to every aspect of the application of GMO technology, particularly in food production, is transparency, consumer information and accurate labelling. In short, the consumer must at all times be given a choice.

  Bernié (EDD). – (FR) Mr President, ladies and gentlemen, European consumers are justifiably concerned about genetically modified organisms and their release. The industrial lobby continues, unscrupulously and in the name of the great god profit, to play the sorcerer’s apprentice, juggling dangerously with food safety and consumer health. It is Europe’s duty to pass stringent legislation that will make these alchemists accountable and to guarantee product quality whilst also providing citizens with clear information.

We totally agree with the line of thinking adopted in this report. The emphasis should be placed on the traceability facilitated by comprehensive information, including that aimed at third countries which import or export GMOs. Indeed, consumer safety calls for equal treatment with a view to avoiding any deflection of trade or the export of products unsaleable on the European market. We must also require the prior approval of the recipient country before any trade can take place.

If the liability of the operator responsible for release is to be officially established, it would also be advisable to define this liability precisely and unhurriedly, in order to avoid introducing an over-general concept of environmental liability. Lastly, the risks to the environment should be assessed via an annual cost-benefit analysis of these GMO releases, carried out in a transparent manner and extended to cover animal and plant health as well as public and private goods.

  Trakatellis (PPE-DE). – (EL) Mr President, there has been a significant increase in biotechnology applications and they are becoming more and more important both to the economy and to society, because using applications derived from genetically-modified organisms will be instrumental in improving our quality of life. Hence, it is essential that we introduce a modern framework governing the development, marketing and exploitation of genetically-modified organisms.

Europe must not be left behind the USA and Japan. This, however, does not mean that we should overlook the safety issues surrounding these innovative applications, such as public health safety and environmental protection. I must point out that we have all witnessed the ongoing war of words recently over the safety of genetically modified organisms. This has led to confusion amongst consumers and has resulted in their being unable to form a sound judgement on the benefits and dangers of biotechnology. We should therefore win consumer confidence and the way to do so is by improving safety standards. For example, we can build up public confidence by banning the creation or use of GMOs containing antibiotic-resistant genes and by providing agencies and the general public with detailed and objective information.

Parliament called at first reading for amendments to be incorporated into this directive which cover the above two objectives, i.e. the creation of a useful framework of rules for the deliberate release and trade in GMOs, accompanied by safety measures for the protection of public health and the environment and information for the public and consumers. It is also important for provision to be made for the directive to be adjusted and amended in line with new developments resulting from the fast pace of change in biotechnology and its applications.

In closing, I should like to dwell on one point which I stressed in the Committee on the Environment and which deserves our particular attention, and that is the issue of safety. We are awaiting a more general proposal from the Commission on product liability and safety. We must not overreact if we want this directive to promote and support such a promising sector.

  De Roo (Verts/ALE). – (NL) Mr President, to genetically modify food means to break through the barrier that divides different species, for example by introducing a fish gene into a strawberry. This is not possible in conventional agriculture. Tinkering with genes holds unknown risks. This is why measures are needed to prevent gene transfer so that this fish gene cannot contaminate conventionally or organically grown strawberries.

According to the gene tech industry, the risks of such unwanted contamination are low. If these risks are so low, why is it then that the gene tech industry refuses to accept any legal liability? But maybe there is a risk for the environment and human health and in those cases, such a liability clause is most definitely needed. The Christian Democrats are playing a dangerous game. Whilst they are in favour of a liability clause in the directive on disposing of dangerous waste, they suddenly want to wait five years when it comes to gene technology. If liability pertaining to gene food is not regulated now, suspicion among the public regarding this type of food will only grow.

The Christian Democratic position will rebound perfectly off the gene industry.

  Sommer (PPE-DE). – (DE) Mr President, genetic engineering and biotechnology are the key technologies of the future. If we in the EU hamper or even block the use of genetically modified organisms, we shall be manoeuvring ourselves into a backwater in this important area. We are already lagging far behind other countries. The resultant competitive disadvantages for researchers, breeders, seed growers, farmers and even consumers would be immense. But it is precisely these obstruction tactics which several groups within the European Union are applying. They of course appear to be rather ideological in nature because generally there are no material grounds for them.

This attempt at obstruction can be found in a series of proposed amendments in the Bowe report. They are distinguished by the fact that they demand the impossible, knowing full well that these demands cannot be met and can therefore block the release of GMOs in general. This applies in particular to genetic transfer, which simply cannot be prevented in the open air, and to the question of liability. The call for special liability means that farmers dare not use GMOs. I also think that keeping a register of cultivated land beyond the experimental stage is unrealistic because I assume that 80-90% of farmland would be entered in such as register in a few years’ time.

No one wants to play down genetic engineering, including me. But nor can we demonise it. Farmers have always endeavoured to use targeted breeding and cultivation techniques in order to develop efficient plant and animal material. Techniques continue to develop, including in breeding and cultivation and one new technique is genetic modification. It is our task to ensure that this technology is used responsibly, not to prevent it.

(Applause)

  Evans, Jillian (Verts/ALE). – Mr President, I would urge colleagues to strengthen this report by insisting on environmental liability. Producers of GMOs should be required to take out insurance against any damage to human health or to the environment from the release of their products. The Commission promised the introduction of horizontal legislation over ten years ago. But even though we now have a White Paper, the actual legislation is some years away. This means that, if it is not accepted into this directive, the victims will have to pay for any damage instead of the companies that are making the profits.

Thousands of people across Europe have chosen not to buy products containing GMOs because of the evidence of health and environmental damage. We must address those very real issues.

I would urge colleagues to accept my group's amendments on liability insurance, GMO contamination and the ban on antibiotic-resistant genes. Consumers are demanding the strictest controls and will be satisfied by nothing less. It is vital that all the necessary safeguards are now included in this directive.

  Rovsing (PPE-DE). – (DA) Mr President, I am pleased that Parliament, in collaboration with the Council, is now finally in a position to give Europe a chance to make its influence felt in the sphere of GMOs. We must be careful, however, that we do not now just sit back in the belief that we have finished our work. We have selected an authorisation procedure which is more restrictive than its American equivalent, and this will of course be significant in terms of our ability to hold onto the best companies and researchers. The time limits we adopt for processing applications should not, therefore, be applied as the rule but, instead, constitute an absolute maximum. We must reject the proposal that the entire liability for any damage should be shifted onto whoever has released the GMOs into the environment. A natural consequence of Europe’s strict authorisation procedure must be that the authorities assume a portion of the liability. Only by sharing the liability between the authorities and businesses in this way will it be possible to offset the competitive disadvantages presented by the laborious approval procedure, and only in this way will be able to compete with the Americans.

  Wallström, Commission. – Mr President, when I started at the Commission last autumn I realised very quickly that the directive on the deliberate release of GMOs would be one of the most sensitive dossiers under my responsibility.

Genetically modified products and biotechnology give rise to a number of questions and concerns. The most important are perhaps: what are the benefits? What are the risks? How do we best avoid possible negative effects? How do we ensure that we have access to all the relevant information?

To tackle these three concerns raised by our citizens we need a wide and open debate where all key players participate and the discussion cannot be limited only to the experts. Here the European institutions, the Member States, industry and science all have to take their responsibilities.

The basis for meeting these new challenges has to be an efficient and transparent legislative framework.

I should especially like to thank the rapporteur, Mr Bowe, and the Committee on the Environment, Public Health and Consumer Policy for their hard work in making a rapid and important contribution.

Our role as European policymakers should be to provide for a balanced response to these new challenges. We need a regulatory framework, based on safety and the precautionary principle which ensure a high level of protection for human health and environment. At the same time, it has to allow society to benefit from the development of modern biotechnology.

Our European legislation on GMOs guarantees an individual and thorough risk assessment of each GMO product placed on the European market.

We are here today to strengthen and improve the existing framework. The sensitivity and complexity of the matter might explain why we are confronted with a total number of 52 amendments at second reading.

The Commission can accept in their entirety Amendments Nos 9, 17, 19, 29 and 47, which improve the quality and the clarity of the texts. The Commission can also accept in principle Amendments Nos 1 to 4, 8, 11, 24, 35 to 38, 46, 48, 49 and 52. They further strengthen the intention of the Commission to establish an efficient transparent and balanced regulatory framework for GMOs.

Let me comment further on Amendment No 1 and Amendments Nos 13, 14 and 28, which all relate to the biosafety protocol and obligations for imports and exports of GMOs. The European Community was one of the driving forces in the successful adoption of the Cartagena Protocol on biosafety in January. The Commission therefore welcomes the spirit of Amendment No 1. This refers to the need to submit the appropriate proposals for the implementation of the protocol when ratified – work has already begun. However, the Commission cannot accept the inclusion of provisions on import and export obligations in the text of the directive. We believe that the implications of the protocol on the overall European Union legislative framework have yet to be fully assessed. Amendments Nos 13, 14 and 28 are therefore not acceptable in the present revision.

Let me now turn to the issue of liability, and I know that this is an important political subject for all of you. When I made my presentation to Parliament in the autumn I promised that I would make particular reference to GMOs in the White Paper on environmental liability. The Commission did exactly that when adopting the White Paper this year. The Commission is of the opinion that a horizontal approach is the most efficient way to guarantee a comprehensive responsibility regime for environmental damage. This will provide clarity for complainants and prevent loopholes. This is also the best way to complement the existing horizontal system for product liability already covering GMOs.

I can assure you that I will do my utmost to be able to present a proposal for legislation on liability before the end of 2001. I can therefore accept Amendments Nos 2, 36 and 46 in principle, as far as they refer to the Commission White Paper. Let us be clear, if this is put in this directive, rules will have to be made to ensure legal clarity, and how long will that take? It must be seen in that context.

However, I cannot accept Amendments Nos 33, 40 and 45. I am also fully aware of the political importance of certain other aspects raised by the proposed amendments. It is clear that antibiotic resistance marker genes need to be phased out and be replaced with alternatives as soon as practically possible. A phase-out is already foreseen in the common position. The Commission agrees to strengthen this political message. The Commission cannot agree to a general ban of GMOs containing antibiotic resistance marker genes. At the moment there is no scientific evidence that all GMOs of this type present adverse effects to human health and the environment. Instead, we should continue to carry out a comprehensive case-by-case risk analysis.

Within these limits, Amendments Nos 11, 37, 48 and 52 are therefore acceptable in principle. The Commission can also accept in principle Amendments Nos 3, 4, 8, 24 and 35 to the extent that they are in line with the logic of the texts and fit within the overall legislative framework. The Commission can therefore agree to a recital concerning socio-economic aspects which refers to the reporting obligation of the Commission. This will be done every three years under Article 30.

The Commission welcomes Amendments Nos 38 and 49 concerning gene transfer. They constitute a balanced approach between a total prevention and a permissive approach. However, the wording should be aligned with the text of the directive. In addition, the Commission reference should be deleted since the Commission does not necessarily play a role under Part B – national consent.

However, the Commission cannot accept Amendment No 12 concerning the prevention of gene transfer. Gene transfer between organisms is, as we know, a common phenomenon in nature. Instead we need to ensure that potential risks from gene transfer are thoroughly assessed before GMO products are released for research or placed on the market.

The Commission cannot accept Amendments Nos 22 and 23 as they stand, since the provisions foreseen in these amendments would not be workable within the authorisation system established by the directive. This is both for administrative and legal reasons.

The Commission, however, acknowledges that these amendments aim at addressing the possible problems that certain industries might face with strict time-limited consent. This concerns in particular the plant breeding industry. The Commission will therefore consider how due account can be taken of these concerns while ensuring political, legal and administrative consistency. In this context, Amendment No 26 is also not acceptable since this would limit the flexibility of the optional time limitation of consent for the renewal.

Amendment No 25 seeks to introduce a provision which allows for the introduction of differentiated procedures under Part C of the directive. This builds on the original proposal as presented at first reading in Parliament. However, this amendment goes beyond the Commission proposal and is therefore not acceptable to the Commission as it stands. The Commission is, however, willing to reconsider this amendment in the light of its original proposal and within the framework of an overall compromise.

Finally, I should like to deal as a package with the amendments I have not yet addressed. The Commission cannot accept Amendment No 21 since the legal basis of future legislative measures is subject to its content and cannot be established in advance by this directive.

Amendment No 6, concerning a centralised Community procedure, is not acceptable. However, I should like to stress that careful evaluation of a centralised procedure would be done in the Commission report required under Article 30 of the directive.

Access to the work of the European Group on Ethics and their opinions is an important of the general evaluation. The Commission is, however, of the opinion that this is already appropriately covered in the Rules of Procedure of the Committee. Amendment No 32 is therefore not acceptable.

Amendments Nos 5, 7, 10, 15, 16, 18, 20, 27, 30, 31, 34, 39, 41 to 44, 50 and 51 are also not acceptable since they would introduce legal and technical uncertainty or jeopardise the overall balance achieved in the common position.

To conclude, we urgently need a revised Directive 90/220. It has to ensure a high level of protection for human health and the environment and, at the same time, allow society to profit from the benefits of these new technologies. To strike the right balance between these two justified concerns we need a transparent process, a wide dialogue and strong political leadership. We all have to take our responsibilities in achieving this, and this is the only way in which we will win the trust and confidence of our citizens.

  Breyer (Verts/ALE). – (DE) Mr President, I think that tomorrow’s vote is so important that I should like to ask the Commissioner to clarify two points so that we know what we are voting on tomorrow.

Commissioner, my first question is this: have I understood you correctly, can you promise that you are making provision for an environmental liability with compulsory insurance, yes or no? I just want a yes or no. Or is it correct that you only agree to liability as set out in the White Paper, i.e. just for Natura 2000 areas and with no compulsory insurance. In plain text, this means that if damage occurs and the person responsible cannot be held liable, the general public, i.e. the taxpayer will pay for it. Can you give Parliament a guarantee – and I should like a yes or no – that compulsory insurance is contained in a horizontal directive?

My second point is this: unfortunately, you did not go into proposed Amendment No 42. Can you confirm that there is no EU legislation for GMOs in contained use? You know that the contained use directive excludes this and, at the same time, Article 2 (4) of the common position makes no provision for regulations on GMOs for contained use. There is a gap in the legislation here and I think that this is very important for tomorrow’ vote. For example, transgenetic fish in contained use would not be covered by the two directives. I should like a clear answer on this.

  President. – I am not reopening the debate. I will give the floor to the Commissioner if she wants to respond to these two specific points, but I thought the Commissioner's response was very clear and comprehensive.

Commissioner, do you wish to reply?

  Wallström, Commission. – Mr President, I shall start with the second part of Mrs Breyer's question. It is true that there is no specific Community legislation for the contained use of genetically modified plants and animals. However, Article 2(4) of the common position obliges Member States to ensure that these GMOs are handed over to a third party only if stringent containment measures are in place, otherwise notification under Part C of the directive is necessary. Amendment No 42 would prevent any exchange of genetically modified plants and animals for research activities under contained use until Community legislation is in force. That is why we cannot accept Amendment No 42.

As you know, we have now issued a White Paper on environmental liability. It is now open for comments and views and we are ready to discuss it because I want to ensure that this environmental liability paper covers GMOs. Your views are also welcome. I intend to ensure that this paper covers GMOs. It already covers product liability. Insurance is one thing we will have to look into in more depth and also get the views of other parties on the practical aspects. The White Paper is a first step, as you know. That has to be discussed in depth and I will come back with a proposal. I believe it will be possible to put an insurance system in place.

  President. – The debate is closed.

The vote will be taken tomorrow at 11.30 a.m.